Orphan Drugs in the European Union

Rules concerning orphan drugs in the European Union are largely inspired by those concerning orphan drugs in the US. Orphan drugs in the European Union are based on and built on the same premise, namely offering support to pharmaceutical companies that manufacture drugs to treat rare diseases.

Regulations on orphan drugs in the European Union

The European Medicines Evaluation Agency (EMEA) has made regulations for the conduct of orphan drugs in the European Union. The whole set of regulations was built on the need for developing rare drugs and making them available at the most affordable cost and in the quickest possible time for the patient.

January 1, 1995 can be considered the date from which rule concerning orphan drugs in the European Union came into existence across the board in the European Union. Till then, the EU was in the process of synchronizing and unifying the fragmented laws on orphan drugs in the European Union across its many countries. From this date, the rules for orphan drugs in the European Union have been uniform across the bloc.

Regulation n° 141/2000

Regulation n° 141/2000 was the first and most important regulation that the EU passed as part of regulation of orphan drugs in the European Union. Passed by the European Parliament in December 1999; its salient features include the following:

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Japanese Institutions and Regulatory Authorities

Japanese institutions and regulatory authorities are organized in a rather complex way, with a few institutions and regulatory authorities being responsible for the oversight of regulating pharmaceuticals, and a few others, purely for developing pharmaceuticals.

The overall regulator of the Japanese institutions and regulatory authorities is the Japanese Ministry of Health, Labor, and Welfare (MHLW), which is an offshoot of the Ministry of Health and Welfare (MHW), with which the credit for framing and implementing most of the current regulations lies.

Japanese institutions and regulatory authorities for regulating pharmaceuticals

The Pharmaceutical and Food Safety Bureau (PFSB), which comes under the MHLW, is the pharmaceutical regulatory authority of Japan. This body is the one that takes decisions relating to application approval.

In addition, Japanese institutions and regulatory authorities consist of two other bodies that work with the pharmaceutical industry on a day-to-day basis. These are:

Although it is admitted that the organization of Japanese institutions and regulatory authorities in such a manner is rather confusing and an effort is underway to merge these three institutions; as of now, this is yet to materialize. There has been some ongoing movement towards creating a superstructure of these three Japanese institutions and regulatory authorities, creating an FDA-like body.

Japanese institutions and regulatory authorities in relation to development of pharmaceuticals

Japanese institutions and regulatory authorities in relation to development of pharmaceuticals are organized in the following manner:

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